Saturday, July 7, 2012

Roche to FDA and NICE: "... off from our business!"

Very interesting news:


Roche ($RHHBY) has again had a cancer treatment rejected by the U.K.'s cost containment agency. This time, the National Institute for Health and Clinical Excellence (NICE) said that while using Avastin with the chemotherapy treatment Xeloda delayed the progression of breast cancer than chemotherapy alone, there was insufficient evidence that patients ultimately lived longer.

It is a tough blow for the drug since breast cancer in Britain is the most common cancer among women. Nearly 50,000 are diagnosed with it each year.

The Swiss drugmaker called the rejection "disappointing," Reuters reports, a milder response than when the agency last month ruled against its targeted melanoma treatment Zelboraf. With that rejection, the company said the decision shows NICE's evaluation process just will not hold up under the country's new plan for "valued-based" pricing, and pointed out the drug overseer has now snubbed 9 of 10 end-of-life cancer drugs.

Avastin, of course, is a different kind of treatment. NICE said it was also uncertain whether Avastin, known generically as bevacizumab, did anything for the patients' quality of life.

Roche had already had the FDA rescind its approval of Avastin for breast cancer treatment last year because the agency didn't believe the risks to patients outweighed the benefits. Avastin is approved in the U.S. as a first line or second line treatment for colorectal cancer, and the company recently released data that starting its continued use with chemotherapy can help patients live longer.


It is worth to deconstruct the situation. As I can read the message: Roche is just saying to FDA and NICE: “... off!” Avasting is targeted to one of the hugest markets and it would be extremely stupid to deprive the company of so fat piece of the prey...

No comments:

Post a Comment